Evaluation of chemical stability of polymers of XIENCE everolimus-eluting coronary stents in vivo by pyrolysis-gas chromatography/mass spectrometry
Evaluation of chemical stability of polymers of XIENCE everolimus-eluting coronary stents in vivo by pyrolysis-gas chromatography/mass spectrometry
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DOI：
10.1002/jbm.b.33979
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发表时间：
2018-07-01
影响因子：
3.4
通讯作者：
Virmani, Renu
中科院分区：
文献类型：
--
作者：
Kamberi, Marika;Pinson, David;Virmani, Renu
聚合物聚（偏氟乙烯-共-六氟丙烯）（PVDF-HFP）和聚（甲基丙烯酸正丁酯）（PBMA）用于生产XIENCE系列冠状动脉支架。PBMA作为底漆，粘附在支架和药物涂层上。在药物基质层中采用PVDF-HFP以将药物依维莫司保持在支架上并控制其释放。通过热解-气相色谱-质谱（Py-GC/MS）检测评价XIENCE支架聚合物在体内环境中的化学稳定性。在本评价中，将分别在植入2-4年和5-7年后尸检时从猪冠状动脉和人体冠状动脉标本中取出的XIENCE支架与新鲜生产的XIENCE支架（对照）进行了比较。支架样品和对照品的热解图比较显示聚合物的断裂指纹相同，表明PVDF-HFP和PBMA在XIENCE冠状动脉支架植入多年后保持其化学完整性。本研究的结果证明了XIENCE系列冠状动脉支架的PVDF-HFP和PBMA聚合物在体内环境中的化学稳定性，并进一步证明了PVDF-HFP作为药物载体适用于药物洗脱支架应用。(c)2017 Wiley Periodicals，Inc. J Biomed Mater Res Part B：Appl Biomater，106 B：1721-1729，2018。
The polymers poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) and poly(n-butyl methacrylate) (PBMA) are employed in manufacturing the XIENCE family of coronary stents. PBMA serves as a primer and adheres to both the stent and the drug coating. PVDF-HFP is employed in the drug matrix layer to hold the drug everolimus on the stent and control its release. Chemical stability of the polymers of XIENCE stents in the in-vivo environment was evaluated by pyrolysis-gas chromatography with mass spectrometry (Py-GC/MS) detection. For this evaluation, XIENCE stents explanted from porcine coronary arteries and from human coronary artery specimens at autopsy after 2-4 and 5-7 years of implantation, respectively, were compared to freshly manufactured XIENCE stents (controls). The comparison of pyrograms of explanted stent samples and controls showed identical fragmentation fingerprints of polymers, indicating that PVDF-HFP and PBMA maintained their chemical integrity after multiple years of XIENCE coronary stent implantation. The findings of the present study demonstrate the chemical stability of PVDF-HFP and PBMA polymers of the XIENCE family of coronary stents in the in-vivo environment, and constitute a further proof of the suitability of PVDF-HFP as a drug carrier for the drug eluting stent applications. (c) 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1721-1729, 2018.